BEUDAMED
    FDA Recall Terminated

    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

    Recall: Z-1797-2018 · Initiated July 14, 2016

    Recall

    Recall Number
    Z-1797-2018
    Event Number
    79621
    Firm
    Diagnostic Hybrids, Inc.
    FEI Number
    1000122536
    Product Code
    CIN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 14, 2016
    Terminated
    August 28, 2020
    Address
    2005 E State St, Ste 100, Athens, OH, 45701-2125

    Description

    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

    Reason

    There is a possibility of low volume and/or leaking standard bottles.

    Action

    Customers were contacted via telephone and a letter dated 7/14/16. The letter instructed customers to review their inventory for the specified lot number, check for any low-volume or leaking standards, and contact the recalling firm if necessary.

    Distribution

    The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.

    Quantity

    1004